Social Anxiety DisorderPhase 4NCT05384483
Cariprazine Versus Placebo for Social Anxiety Disorder
A Phase 4 study testing Cariprazine in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site in United States.
Trial summary
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cariprazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2022to 15 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults between 18 and 65 years of age (inclusive).
- Subjects must give written informed consent prior to any study procedures.
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Anxiety Disorder) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits.
- Subjects must have a total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at the Screening and Baseline visits.
- Subjects must have a Clinical Global Impression of Severity (CGI-S) score of 4 or greater at both Screening and Baseline visits.
- All subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial and for at least 4 weeks after it ends. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices. Abstinence from heterosexual intercourse will also be considered an effective form of contraception, if abstinence is part of the subject's usual lifestyle.
Who cannot join
- Subjects with any Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), dysthymia, or specific phobias will be allowed if SAD is the primary disorder in terms of clinical severity, as determined by the investigator.
- Subjects with any history or complication of schizophrenia or bipolar disorder.
- Subjects with a complication of body dysmorphic disorder.
- Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of the Baseline visit.
- Subjects who are currently pregnant, lactating, or of childbearing potential and not able and willing to practice an effective method of contraception for the duration of the trial and at least 4 weeks after the final study visit.
- Subjects scoring >2 on item #3 of the HAM-D at Baseline, or who, in the opinion of the PI, are at a clinically significant risk for suicide.
Show all 22Show fewer
- Significant risk for suicidal behavior during the course of study participation, in the opinion of the investigator, or recent (within the last 6 months prior to screening) suicidal behavior defined as scoring "yes" on items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline, or any suicide attempt within the 6 months prior to screening.
- Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits.
- Positive Urine Drug Screen at the Baseline visit, unless due to prescribed medication.
- Any current unstable and/or clinically significant medical condition, based on history or as evidenced in screening laboratory or ECG assessments.
- Current diagnosis of Diabetes Mellitus (type 1 or 2).
- Current diagnosis or past history of significant cardiovascular disease.
- Screening laboratory results showing: transaminases (ALT or AST) greater than 2 times the upper limit of normal (ULN) at screening, absolute neutrophil count (ANC) < 1000 at screening, or active Hepatitis B or Hepatitis C.
- Subjects with a history or complication of cancer or malignant tumor not in remission for at least 5 years. Basal cell skin cancers are not exclusionary.
- Any history of seizure or seizure disorder, with the exception of a single childhood febrile seizure.
- Subjects for whom cariprazine is contraindicated.
- Subjects receiving fluoxetine within 28 days of the Baseline visit.
- Subjects receiving Monoamine Oxidase Inhibitors (MAOIs) within 14 days of the Baseline visit.
- Subjects receiving any other psychotropics (including but not limited to: gabapentin, pregabalin, antipsychotics, Selective serotonin reuptake inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), benzodiazepines, and sedative hypnotics other than zolpidem) within 14 days of the Baseline visit. Zolpidem (Ambien®) taken as needed (PRN) is allowed for insomnia if not taken more than 3 times per week.
- Subjects who started psychotherapy or Cognitive Behavioral Therapy (CBT) within 24 weeks of the Baseline visit, except for supportive psychotherapy. Subjects who have been receiving psychotherapy or CBT for more than 24 weeks prior to the Baseline visit are eligible provided that the therapy continues at the same frequency for the duration of the trial.
- Subjects receiving electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit.
- Treatment refractory SAD, defined for this study as: subjects who have a history of two or more failed treatment trials with an FDA-approved SAD treatment, whereby a treatment trial is defined as a period of at least 6 weeks during which the subject received an adequate dosage of the SAD treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical Research Network, LLC
New York, New York, 10128
About this study
Official title: Vraylar® (Cariprazine) in the Treatment of Social Anxiety Disorder: A Double-Blind Study
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.
Read the detailed description
Social Anxiety Disorder is recognized as a prevalent, chronic and disabling condition (Schneier et al, 1992). Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey (NCS (Magee et al, 1996)). The age of onset of Social Anxiety Disorder (SAD) is early, usually in the teenage years, and social, academic and vocational impairment are often severe (Schneier et al, 1992; Stein et al, 2000). Depression and alcohol abuse are common sequelae.
There is a need for more therapeutic agents for Social Anxiety Disorder. At this time, only Paxil (paroxetine), Zoloft (sertraline), Luvox CR (fluvoxamine maleate), and Effexor XR (venlafaxine) are approved. However, each of these agents helps only about 45-55% of a given sample. Furthermore, the majority of those considered responders after an acute trial are still clinically symptomatic. The same can be said for the most effective form of psychosocial treatment for social anxiety disorder, Cognitive Behavior Therapy (CBT) (Heimberg et al, 1998), and other effective drug treatments such as phenelzine (Liebowitz et al, 1992) and clonazepam (Davidson et al, 1993). In addition, all of the drug treatments found effective to date have troubling adverse effects such as weight gain, sexual dysfunction, physical dependency, or inducing tolerance that can make long term use difficult. Thus, additional treatments are needed for Social Anxiety Disorder.
Vraylar® should be helpful for patients with SAD. It is a partial agonist at D2 and D3 receptors with affinity as well for a variety of serotonin receptors including 5-HT1A, 5-HT 2A 5-HT 2C and 5-HT 7. While it has been most extensively studied for its antipsychotic and anti-manic properties, its serotonergic and dopaminergic receptor profile suggests it may also be helpful for anxiety states. Social Anxiety Disorder is an excellent area to assess a medication's anti-anxiety properties. The disorder's high prevalence makes study enrollment fairly straightforward. Its chronicity mitigates against placebo response, which has been in the 30% range in most placebo-controlled trials. The most commonly used rating instrument for SAD, the Liebowitz Social Anxiety Scale (LSAS), has demonstrated validity and reliability. Most striking is the consistency and reproducibility of results from one trial to the next with the same agent. Registration trials for Zoloft® were 2 for 2 positive, for Paxil® 3 for 3, and for Effexor® XR 5 for 5. Finally, medications found effective for SAD have also been shown to work in generalized anxiety disorder, suggesting SAD as a good indication for proof of concept studies to test a medication's antianxiety properties.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cariprazine, Placebo
- Keywords
- SAD, Social Anxiety, Social Phobia, Social Anxiety Disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CariprazineDrug
Also called Vraylar®
Cariprazine 1.5 to 3 mg per day
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine | Experimental | Cariprazine 1.5 to 3 mg per day Receives: Drug: Cariprazine |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LSAS Score
The primary outcome measure is the change in the Liebowitz Social Anxiety Score from Baseline to study endpoint (Week 12 or Last Observation Carried Forward (LOCF))
Measured: 12 Weeks or LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start18 Jul 2022
- Primary completion4 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medical Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Michael R Liebowitz, MD, Principal investigator, Managing Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384483
- Sponsor's protocol ID
- VRA-MRN-S40
- Status last verified
- Aug 2024
- First submitted
- 17 May 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vraylar® (Cariprazine) in the Treatment of Social Anxiety Disorder: A Double-Blind Study
- ClinicalTrials.gov ID
- NCT05384483
- Acronym / sponsor ID
- VRA-MRN-S40
- Conditions
- Social Anxiety Disorder
- Keywords
- SAD, Social Anxiety, Social Phobia, Social Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Medical Research NetworkUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.
Detailed description
Social Anxiety Disorder is recognized as a prevalent, chronic and disabling condition (Schneier et al, 1992). Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey (NCS (Magee et al, 1996)). The age of onset of Social Anxiety Disorder (SAD) is early, usually in the teenage years, and social, academic and vocational impairment are often severe (Schneier et al, 1992; Stein et al, 2000). Depression and alcohol abuse are common sequelae.
There is a need for more therapeutic agents for Social Anxiety Disorder. At this time, only Paxil (paroxetine), Zoloft (sertraline), Luvox CR (fluvoxamine maleate), and Effexor XR (venlafaxine) are approved. However, each of these agents helps only about 45-55% of a given sample. Furthermore, the majority of those considered responders after an acute trial are still clinically symptomatic. The same can be said for the most effective form of psychosocial treatment for social anxiety disorder, Cognitive Behavior Therapy (CBT) (Heimberg et al, 1998), and other effective drug treatments such as phenelzine (Liebowitz et al, 1992) and clonazepam (Davidson et al, 1993). In addition, all of the drug treatments found effective to date have troubling adverse effects such as weight gain, sexual dysfunction, physical dependency, or inducing tolerance that can make long term use difficult. Thus, additional treatments are needed for Social Anxiety Disorder.
Vraylar® should be helpful for patients with SAD. It is a partial agonist at D2 and D3 receptors with affinity as well for a variety of serotonin receptors including 5-HT1A, 5-HT 2A 5-HT 2C and 5-HT 7. While it has been most extensively studied for its antipsychotic and anti-manic properties, its serotonergic and dopaminergic receptor profile suggests it may also be helpful for anxiety states. Social Anxiety Disorder is an excellent area to assess a medication's anti-anxiety properties. The disorder's high prevalence makes study enrollment fairly straightforward. Its chronicity mitigates against placebo response, which has been in the 30% range in most placebo-controlled trials. The most commonly used rating instrument for SAD, the Liebowitz Social Anxiety Scale (LSAS), has demonstrated validity and reliability. Most striking is the consistency and reproducibility of results from one trial to the next with the same agent. Registration trials for Zoloft® were 2 for 2 positive, for Paxil® 3 for 3, and for Effexor® XR 5 for 5. Finally, medications found effective for SAD have also been shown to work in generalized anxiety disorder, suggesting SAD as a good indication for proof of concept studies to test a medication's antianxiety properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine | Experimental | Drug: CariprazineCariprazine 1.5 to 3 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female adults between 18 and 65 years of age (inclusive).
- Subjects must give written informed consent prior to any study procedures.
- Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Anxiety Disorder) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
- Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits.
- Subjects must have a total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at the Screening and Baseline visits.
Key exclusion criteria (22 listed)
- Subjects with any Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), dysthymia, or specific phobias will be allowed if SAD is the primary disorder in terms of clinical severity, as determined by the investigator.
- Subjects with any history or complication of schizophrenia or bipolar disorder.
- Subjects with a complication of body dysmorphic disorder.
- Substance use disorder, as defined by DSM-5 criteria, within 24 weeks of the Baseline visit.
- Subjects who are currently pregnant, lactating, or of childbearing potential and not able and willing to practice an effective method of contraception for the duration of the trial and at least 4 weeks after the final study visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CariprazineAlso: Vraylar®Cariprazine 1.5 to 3 mg per day | Drug | Cariprazine |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Change in LSAS Score
Time frame: 12 Weeks or LOCF
The primary outcome measure is the change in the Liebowitz Social Anxiety Score from Baseline to study endpoint (Week 12 or Last Observation Carried Forward (LOCF))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Liebowitz, MD principal investigator
Managing Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cariprazine in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LSAS Score (time frame: 12 Weeks or LOCF). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.